Neural Correlates of Lidocaine Analgesia (NeuCLA)

Keith M Vogt

Status and phase

Completed

Phase 1

Conditions

Pain

Anesthesia

Treatments

Device: Peripheral Nerve Stimulation

Drug: Lidocaine IV

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05501600

R35GM146822 (Other Grant/Funding Number)

STUDY21120115

Details and patient eligibility

About

The purpose of this study is to characterize the effects of intravenous lidocaine on pain processing and cognitive function. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will consist of 1 visit and involves no long-term follow up.

Full description

This is an observational cohort study of volunteer subjects, which will employ neuroimaging and behavioral measures to characterize the effects of intravenous lidocaine on pain processing and cognitive function. A steady-state effect-site concentration of lidocaine will be achieved, and a short battery of cognitive behavioral tasks will be employed. At the dose target, pain task functional MRI and resting-state connectivity will be determined. This work will use a systems neuroscience approach to fill an important knowledge gap about the central effects of intravenous lidocaine, a commonly-used opioid alternative analgesic agent.

Aim1: Determine cognitive behavioral effects of a steady-state dose of IV lidocaine using a short battery of tasks. The investigators hypothesize that the administration of lidocaine will correlate to decreased pain ratings, slowed psychomotor response, and decreased memory encoding.

Aim2: Determine the neural effects of a steady-state dose of IV lidocaine in response to acute pain, and on resting connectivity. The investigators hypothesize that pain task-related activation will decrease in the insula and anterior cingulate, corresponding to decreased ratings of pain intensity and unpleasantness. Additionally, the investigators expect widespread decreases in long-range functional connectivity between brain areas know to be involved in these two areas and other known to be involved in pain processing.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults aged 18 to 70
Be of normal body-weight
Be generally healthy
Have none of the specific exclusion criteria
Have a valid email address and phone number throughout the study

Exclusion criteria

Pregnancy
Body mass index > 40
Having moderate to severe sleep apnea
Having chronic pain requiring the regular use of pain medicine 3 or more times per week
Having neurologic or psychiatric disease, including benign tremor, anxiety, and depression
Having a history of seizures
Having history of cardiac rhythm disturbance (such as heart block, or atrial fibrillation)
Being severely claustrophobic
Having metal implants or non-removable metal piercings
Having metal-containing tattoos, particularly on the face
Having a history of adverse reaction to lidocaine
Are regularly taking: antiepileptics, antidepressants, anti-psychotics, anti-anxiety medication, stimulants, sleep-aids, or pain medication
Are taking prescribed medications for psychiatric or neurological conditions
Having hypersensitivity to lidocaine or to any other local anesthetics of the amide type
Having Wolff-Parkinson-White syndrome
Having known renal or hepatic dysfunction
having glucose-6-phosphate dehydrogenase deficiency or history of methemoglobinemia